The present invention is generally related to hypodermic syringes and more particularly to syringes that include a needle that is retractable after the intended use to substantially prevent inadvertent exposure to the needle and reuse of the syringe.
Hypodermic syringes are widely used in the medical arts for administering medicaments and for drawing body fluid samples. Generally, hypodermic syringes have a metal needle attached either fixedly or removably that has a sharpened distal point for penetrating vial stoppers or patient""s skin. The hypodermic syringes and needles have been used for many years with few problems reported when the vast numbers and needles being used are considered. More recently, with the recognition of viral diseases that are transmitted by body fluids and greater sensitivity of the need to protect health care workers from inadvertent contact with previously used needles (commonly referred to as xe2x80x9csharpsxe2x80x9d) as well as the need to reduce criminal misuse of improperly disposed of needles and syringes, syringes and needles that include provisions to prevent reuse have been developed.
Provisions intended to prevent reuse of needles and syringes include a variety of sharps collector systems that are widely used in health care facilities. Other developments include needle attachments that may be readily broken off by practitioners once the syringe has completed its intended use. A variety of shielding mechanisms has been developed; some of which are currently commercially available. While many of these developments have reduced the incidence of inadvertent exposure of healthcare workers to sharps, most of these devices can readily be overcome by an individual determined to obtain and misuse a hypodermic syringe and needle. As a result of this problem, further developments in the art of hypodermic syringes have resulted in syringes with needles that withdraw into the body of the syringe once their intended use is completed.
U.S. Pat. No. 4,838,869 discloses a retractable hypodermic needle configured for one time use wherein the needle is spring loaded and automatically irretrievably retracted into the hypodermic syringe when the syringe plunger is fully depressed, whereby protrusions on the end of the plunger engage tabs holding the spring loaded needle to release the needle for retraction. A potential problem with the design disclosed in this patent is that many times a practitioner may draw and expel a fluid several times during preparation for administration of a medicament, with this design, the practitioner could inadvertently discharge the retraction mechanism. Further, the design would be very difficult to manufacture in large volumes.
U.S. Pat. No. 4,900,307 discloses a hypodermic needle with an enlarged hub that provides provisions for selectively withdrawing the needle into the hub once the syringe and needle have completed their intended usage. While this disclosed design does substantially eliminate the problem of premature discharge of the retraction mechanism, the enlarged hub has a considerable xe2x80x9cdead volumexe2x80x9d that would result in a significant undeliverable retention of the medicament. Additionally, although the needle is secured in the hub after discharge, the syringe itself is still fully functional after the hub with the needle inside is removed.
U.S. Pat. No. 4,994,034 discloses a hypodermic injection system with a retractable needle wherein the needle retracts within the interior cavity of a syringe plunger. The disclosed invention includes a cylindrical spring housing with resilient fingers which capture a coiled spring that biasly holds a needle holder against the retaining force of the resilient fingers. The plunger in this disclosure has a frangible end, which when engaging the resilient fingers under a pre-determined amount of force, dissociate which remaining inwardly-tapered shoulders spread the resilient fingers, allowing the coiled spring to eject the needle and its holder into the interior cavity of the syringe plunger. A syringe manufactured using this disclosure would be complex and difficult to assemble. It is believed that no successful commercial product has been produced using this disclosure.
U.S. Pat. No. 5,019,044 discloses a safety hypodermic syringe with a hypodermic needle fixed connected to a holder plate and constantly supported by a spring for making axial movement. The holder plate is normally retained by a clamp at a ready position for injection. When the plunger of the syringe is pushed to the bottom of the barrel, the needle is released from the clamp and is pushed by the spring to drop and further follow a rubber plug to be squeezed into a chamber in the plunger. Again, no successful commercial product has resulted from this disclosure, which would be complex to manufacture and appears to have a considerable undeliverable dead volume.
Another example of a syringe with a retractable needle is disclosed in U.S. Pat. No. 5,053,010. The disclosed syringe retracts the needle into a hollow plunger additional pressure on the plunger after the contents of the syringe are expelled. The disclosed design incorporates a sliding elastomeric seal which displaces from its forward position to a retracted position, thereby allowing additional forward travel of the plunger to actuate the retraction mechanism. A problem reported with this design is that, because of the soft nature of the seal, the seal may be prematurely displaced during its use in an injection. Attempts to overcome this difficulty by increasing the stiffness of the sealing member could impair the seal integrity.
U.S. Pat. No. 5,180,369 discloses a self-destructive syringe assembly having a needle cannula fixed to a slidable piston. The slidable piston and slidable piston flange are held within the barrel of the syringe assembly by a compressed spring, a guide tube and a shatter ring. The plunger of the syringe assembly is a hollow elongated tube with a thumb flat at one end, a sliding gasket, a plunger shatter plate and a hook rim at the other end. The patent reports that when medicament is injected, the elongated hollow plunger is further thrust into the shatter ring, the shatter ring shatters, further allowing the slidable piston and slidable piston flange to thrust into the plunger shatter plate to shatter. The shattering of the plunger shatter plate causes the slidable piston and needle cannula to be thrust into the hollow plunger by the spring and is thus prevented from re-entering the guide tube. Again, no successful commercial product has resulted from this disclosure.
U.S. Pat. No. 5,180,370 discloses a syringe which has an internal mechanism for retracting the needle into the syringe after the injection has been given. In one disclosed embodiment, the needle is manually retracted by pulling back on the plunger, and in another, the needle is propelled by a compressed spring into a hollow chamber within the plunger. A syringe produced with this disclosure would be complex to manufacture, and no successful commercial product has resulted from this disclosure.
U.S. Pat. 5,188,599 discloses a hypodermic injection system with a needle that retracts within an interior cavity of the syringe plunger. The needle when retracted is held within the plunger. The disclosed device includes a cylindrical spring housing that has resilient fingers which capture a spring under bias holding a needle holder against the retaining force of resilient fingers. The plunger has a frangible end which dissociates when the outwardly tapered shoulders spread the resilient fingers, allowing the coiled spring to eject the needle and its holder into the interior cavity of the syringe plunger. The patent also discloses a body fluid sampling device that includes a double-ended needle for communication with an evacuated blood collection tube. This patent also includes a review of several earlier disclosures related to retractable needles. Attempts have been made to produce commercial products based on the disclosures of this patent, but as yet there is no successful commercial product.
U.S. Pat. No. 5,201,710 discloses a syringe fitted with a clamping device for the needle and with a mechanism to enable the needle to be automatically retractable into the syringe body at the end of an injection. The disclosed device includes inner and outer cylinders, openings at the ends of the outer cylinder, a third opening at an end of the inner cylinder and a closure for the third opening. The disclosed device further includes a needle with a head, a seal, a first spring to push the needle against the closure and a clamping device loaded by a second spring to maintain outward to the syringe and to release the needle. There is a diaphragm in the closure that bends before breaking and a sharp element to break the diaphragm. There also is a closure to prevent the needle from being accessible and a stop to prevent the second cylinder from being moved outwardly after the syringe is used. As is apparent from the description, the device disclosed by this patent is complex and would be difficult to assemble. No successful commercial product has resulted from the disclosure in this patent.
U.S. Pat. No. 5,385,551 discloses a non-reusable medical device that has a needle which is retractable by depression a plunger slidably mounted in the device. The disclosed device includes a front-mounted retraction mechanism that has a needle holder connected to the needle. The needle holder is supported along the axis of the device by a frictionally engaged retainer ring member coupled to the needle holder along an axially aligned sliding interface. The needle holder and retainer are positioned in the front portion of a hollow body. The front of a movable member or plunger presses against the retainer member passing around the needle holder which cannot move forward, thereby separating the retainer from the needle holder. The separation occurs by gradually reducing the extent of the sliding interface area until the retainer member pops loose from the needle holder whereupon the needle holder and needle are retracted into a cavity in the plunger in response to a retraction force applied to the needle holder by a previously compressed spring. Again, the device disclosed in this patent is complex, difficult to manufacture and appears to have significant undeliverable dead volume. Attempts have been made to commercialize products from this disclosure with only limited success.
U.S. Pat. No. 5,407,436 discloses a hypodermic syringe that has a hollow needle that is automatically retractable after use. The disclosed syringe includes a one-piece body molding has a main chamber for a plunger, sample container or drug cartridge, a forward chamber to house a spring to bias a needle holder, and internal latching formations to retain the needle holder with the spring compressed in the forward chamber until automatic retraction when the latching formations are released by end of plunger movement. The patent discloses that the sealing between the plunger and the body is accomplished by an over-sized plunger head that forces head and wall deformation. The disclosed spring has seals at both ends for the forward chamber. The patent teaches that the needle, its holder, spring and seals can be installed using a sliding guide. In using a syringe produced using this disclosure, the practitioner would need to exercise care when drawing and expelling a fluid during filling, because the retraction of the needle is activated by depressing the plunger sufficiently to engage cooperating latches. The engagement occurs at the bottom of the stroke to expel fluid from the syringe.
U.S. Pat. No. 5,769,822 discloses a non-reusable syringe with a hollow plunger that has a seal member thereon. The position of the plunger and the seal relative to the barrel permits the plunger, with sufficient strength, to carry applied pressure through the device during injection of a fluid and yet permit the seal disposed at one end of the plunger to have maximum sealing integrity between the plunger and a cylindrical barrel disposed around the exterior of the plunger to abate leakage of the liquid in a chamber within the barrel, as the plunger is manipulated from an expanded position to and expended position and thereafter to a third or collapsed position.
U.S. Pat. No. 6,010,486 discloses a retracting needle syringe that substantially prevents reuse of the syringe by destroying the plunger rod and the needle hub and additionally, retracts the needle into the plunger rod. The disclosed syringe includes provisions that upon fully depressing the plunger rod and applying distally directed axial force, a frangible portion of the inner hub is broken and the plunger tip dislodges to allow a spring to urge a cutter to open the chamber inside the plunger.
Most of the devices discussed in the above referenced disclosures are somewhat complex, and many require manufacture and assembly of parts with potentially difficult assembly or tight tolerance requirements. Many of the designs depend upon a careful application of forces by the practitioner to draw and expel fluids from the syringe. Also, if the tolerances between the multiple components of the device are not carefully adhered to during manufacture and assembly, normal usage may result in premature activation of the retraction function of the syringe. Current conventional syringes are considered by users to be virtually fault-free and reliable. They are used for a variety of different procedures involving both xe2x80x9cone-shotxe2x80x9d fill and inject procedures, as well as more complex mixing, measuring and delivery functions. In order for a retractable syringe to displace these functional, utilitarian and reliable conventional syringes, the retractable syringe should not significantly interfere with the users current practices, it needs to be substantially reliable and its cost should not be prohibitive. Current conventional syringes are often manufactured at rates of several hundred per minute and their cost is generally not a significant factor in their usage. Additionally every year, hundreds of millions of small capacity (one milliliter) syringes are used outside of the normal controlled health care environment by diabetics and other self-injectors who must daily accurately inject small amounts, often only a few tenths of a milliliter. These small capacity syringes are physically quite small, with an overall length of less than five inches and an inside bore diameter of less than one-quarter inch. Reviewing the disclosures above, one skilled in the art of high volume manufacturing recognizes that assembling hundreds of millions of most of these relatively complex devices with their retraction elements contained in such a small space as a one-quarter inch diameter bore is a daunting task. Additionally, many of the disclosed devices have substantial undeliverable xe2x80x9cdead volumesxe2x80x9d that substantially confound many diabetics"" need for accurate measuring, mixing of more than one type of insulin in the syringe and delivering small doses of insulin. The need thus exists for a selectively retractable syringe that is compatible with a small capacity syringe, that is capable of being manufactured at high volumes and is sufficiently non-complex to be reliable in use when produced at volumes of hundreds of millions per year. Such a device is disclosed herein below.
A hypodermic syringe with a selectively retractable needle of the present invention includes an elongate barrel having an open proximal end and a distal end that defines a receiver with an inwardly projecting shoulder. The barrel has a hollow bore therethrough with an inside surface extending from the proximal end to the distal end. The syringe of the invention has a hollow elongate plunger with an open proximal end and a closed distal end. There is an elongate plug extending distally into the hollow plunger from the open proximal end forming an enclosed cavity within the plunger. The distal end of the plunger forms a slidable seal with the inside surface of the barrel to define a chamber for drawing and expelling fluid. The syringe also has an elongate hub having a passageway therethrough, a distally extending stem, and a proximal flange with an engagement for engaging the barrel. The stem is disposed within and sized for slidable movement within the receiver at the distal end of the barrel. The flange has a distal surface with a groove therein and a proximal surface defining the chamber in the barrel. The syringe of the invention has an elongate needle having a fluid path therethrough, a sharpened distal end and a proximal end. The needle is mounted in the passageway in the hub so that the sharpened distal end projects distally outwardly and the fluid path is fluidly communicative with the chamber in the barrel. The syringe also has an elongate spring disposed about the stem of the hub that is compressed between the flange and the inwardly projecting shoulder of the receiver to provide a bias. There is a hollow sleeve sized to fit within the receiver over the elongate spring. The sleeve has a distal end disposed at shoulder and a proximal end with a sharpened edge that is disposed in the groove in the distal surface of the flange. When a user applies a sufficient force, a force greater than necessary to expel fluid from the chamber, to the plunger, the hub is sufficiently moved distally in the receiver for the cutting edge of the sleeve to cut through the flange and the closed distal end of the plunger to expose the cavity in the plunger. When the cavity in the plunger is exposed, the bias of the spring urges a sufficient movement of a cut portion of the hub having the needle mounted therein, a cut portion of the distal end of the plunger and the sleeve into the cavity in the plunger to a position wherein an inadvertent exposure of the sharpened distal point is substantially prevented.
The syringe of the invention has an undeliverable xe2x80x9cdead-spacexe2x80x9d volume substantially similar to fixed needle xe2x80x9clow dead-spacexe2x80x9d conventional syringes, i.e., substantially no undeliverable volume. The syringe of the invention is as suitable for use in drawing, measuring, mixing and delivering small volumes of medicaments as conventional syringes. Unlike many of the devices disclosed above, the syringe of the invention is substantially unlikely to be inadvertently retracted by a user following currently used practices and procedures. The syringe of the invention does not depend on a user having to exercise substantially more care than with a conventional syringe when drawing and mixing fluids in the syringe to avoid inadvertent activation, and importantly, the syringe of the invention is compatible with the efficiency of high volume automated manufacture that utilizes much existing manufacturing equipment. Once needle is retracted in the syringe of the invention, the syringe cannot be restored to functionality, as the hub flange is cut through and the plunger is cut through rendering the syringe substantially unusable and protecting the needle point from inadvertent contact by anyone.
An alternate embodiment of the syringe of the present invention includes an elongate barrel having an open proximal end and a distal end defining a receiver. The barrel also includes a hollow bore therethrough. A hollow elongate plunger having a proximal end and a distal end defining a cavity therein is provided. The distal end of the plunger forms a slidable seal with the inside surface of the barrel. An elongate hub comprises a passageway therethrough including a distally extending stem, and a proximal flange with an engagement for engaging the barrel. The stem being disposed within and sized for movement in the receiver at the distal end of the barrel. The flange of the hub includes a distal surface and a proximal surface. An elongate needle having a fluid path therethrough is connected to the stem of the hub so that the passageway is in fluid communication with the chamber of the barrel. An elongate spring is disposed about the stem of the hub. The spring is compressed to provide a biasing force to the flange. A hollow sleeve sized to fit within the receiver includes a distal end and a proximal end having a cutting edge facing the distal surface of the flange of the hub so that when the user supplies a sufficient force, greater than a force necessary to expel fluid from the chamber, to the plunger, the hub is sufficiently moved distally in the receiver for the cutting edge of the sleeve to cut through the flange and the closed distal end of the plunger to expose the cavity therein. This allows the bias of the spring to urge a sufficient proximal movement of the cut portion of the hub having the needle mounted therein and the cut portion of the distal end of the plunger into the cavity. In the event that the frictional force between the inside of the sleeve and the cut portions of the hub and the plunger is greater than the frictional force between outside of the sleeve and the remaining portions of the hub and the plunger, the spring will move the from its position in the receiver so that the cut portion of the hub, the cut portion of the distal end of the plunger and the sleeve move into the cavity. If the frictional force on the outside of the sleeve is greater than the frictional force on the inside of the sleeve the sleeve will remain in its position in the receiver while the cut portion of the hub and the cut portion of the distal end of the plunger move into the cavity.
An operable retracting needle assembly for use with a syringe barrel assembly includes a syringe barrel having an inside surface defining a chamber, an open proximal end, an open distal end including a needle assembly engaging structure and a distally-facing annular sealing surface. The syringe barrel assembly also includes a hollow elongate plunger having a proximal end and a closed cuttable distal end defining a cavity therein. The distal end of the plunger forming a slidable seal with the inside surface of the barrel. The retracting needle assembly comprises an outer hub having a proximal end, a distal end and an inside surface defining a conduit therethrough. A proximal-facing annular sealing surface and an inwardly directed shoulder in the conduit are provided. The outer hub includes means for connecting the outer hub to the needle assembly engaging structure of the syringe barrel so that the proximally-facing annular sealing surface contacts the distally-facing annular sealing surface of the syringe barrel. An elongate inner hub includes a passageway therethrough, a distally extending stem, and a proximal flange with an engagement for releasably engaging the conduit of the outer hub. The stem is disposed within and sized for slidable movement within the cavity of the outer hub. The flange includes a distal surface and a proximal surface. A needle having a sharp distal end, a proximal end and a passageway therethrough is provided. The proximal end of the needle is mounted in the passageway of the inner hub so that the sharp distal end projects distally outwardly. An elongate spring is disposed around the stem of the inner hub and is deflected to provide a bias between the flange and the inwardly projecting shoulder. A hollow sleeve is sized to fit and is positioned within the conduit of the outer hub over the spring. The sleeve includes a distal end disposed at the shoulder and a proximal end having a sharp edge facing the distal surface of the flange so that when the needle assembly is installed on the syringe assembly and a distally directed force, greater than the force required to expel fluid from the chamber, is applied to the plunger, the inner hub is moved sufficiently distally in the outer hub for the sharp edge of the sleeve to cut through the flange and the closed distal end of the plunger to expose the cavity therein. This allows the bias of the spring to urge a sufficient proximal movement of a cut portion of the hub having a needle mounted therein and a cut portion of the distal end of the plunger into the cavity in the plunger to a position wherein inadvertent exposure of the sharp distal point is substantially prevented. The needle assembly may also include an elongate hollow needle shield having a distal end, and an open proximal end removably engaged to the needle assembly so that the needle shield covers the needle.
The retracting needle assembly may include engagement structure wherein the inside surface of the conduit of the outer hub has one of a depression therein or a protuberance thereon, and wherein the flange of the inner hub has a conjugate to one of the depression and the protuberance, so that when the stem is disposed in the conduit with the spring compressed between the flange and the shoulder, the conjugates are engaged thereby releasably retaining the inner hub in the outer hub.
The retracting needle assembly may also contain a sleeve having an outward step adjacent to its proximal end. The step serves to accept the cut portion of the flange to reduce resistance to the advancement of the cutter into the distal end of the plunger. The needle assembly may also be sealed in a package formed of material substantially resistant to the passage of microorganisms and further exposed to conditions that render any microorganisms therein substantially non-viable.